Stroke Clinical Trial
Official title:
A Randomized Controlled Trial to Explore Effect of Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident
The aim of this clinical trial is to compare the psychological condition and experience of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare the psychological condition and experience of the two groups.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age>18 years. - Meeting the diagnostic criteria for ischemic stroke . - Dysphagia confirmed by video fluoroscopic Swallowing Study. - Clear consciousness. - Stable vital signs. Exclusion Criteria: - Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, etc. - Complicated with severe liver and kidney failure, tumors, or hematological disorders. - Simultaneously in need to undergo other therapy that might affect the outcomes of this study. - Pregnant or nursing females. |
Country | Name | City | State |
---|---|---|---|
Thailand | Khon Kaen Hos. | Khon Kaen |
Lead Sponsor | Collaborator |
---|---|
Zeng Changhao |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Generalized Anxiety Disorder 7 | Generalized Anxiety Disorder-7 is a widely used questionnaire to assess the severity of symptoms related to generalized anxiety disorder. The questionnaire consists of 7 questions, each with different answer options. The respondent needs to select the appropriate answer based on their actual condition and assign a corresponding score. The total score ranges from 0-21, with higher scores indicating more severe symptoms. | day 1 and day 15 | |
Secondary | Patient Health Questionnaire-9 | The total score of the Patient Health Questionnaire-9 ranges from 0 to 27, with higher scores indicating more severe depression symptoms. | day 1 and day 15 | |
Secondary | Self-made questionnaire | By conducting a self-made questionnaire, we can assess patients' feelings of fear, shame, uncertainty, and other emotions related to tube feeding. The scores are then converted to a percentage scale ranging from 0 to 100. In the Likert 5-point scale, higher scores indicate worse and more severe conditions for each question. | day 1 and day 15 | |
Secondary | The Reintegration to Normal Living Index | The Reintegration to Normal Living Index is a questionnaire used to assess the extent to which individuals have reintegrated into normal life following a stroke. It includes various domains, including social aspects of reintegration. The total score range for the scale is from 0 to 100, and a higher score indicates better reintegration into normal living. Therefore, in the case of the scale, a higher score is considered more favorable as it reflects a greater degree of reintegration into normal life following a stroke. | day 1 and day 15 |
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